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Operational guideline: Inspection of evidence showing that control measures are effective

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.

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1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on the process to follow and inspection activities to perform when verifying if the control measures used by a food business are effective.

This document is intended to be used in conjunction with other guidance documents as referenced in step 3.0.

The guidance outlined below should be used when, in the course of an inspection of a preventive control plan, the inspectorate is verifying that validated control measures are being applied.

2.0 Authorities

3.0 Reference documents

4.0 Definitions

Unless specified below, definitions are located in either the:

Quantitative
Expressible in terms of quantity; involving the measurement of quantity or amount.

5.0 Acronyms

Acronyms are spelled out the first time they are used in this document and are consolidated in the Food business line acronyms list.

6.0 Operational guidance

Control measures recognized in an industry guidanceFootnote 1 document published by the Canadian Food Inspection Agency (CFIA) are considered to have already been validated as effective (pre-validated control measure) when used by a food business under the same conditions as described in the guidance. However, when new or alternative control measures are used, the food business must validate that these control measures are effective. The industry guidance document Evidence showing a control measure is effective provides guidance to industry on the regulatory requirements for validating control measures and how to gather and document the evidence. The industry guidance should be consulted when carrying out inspection activities to assess if a food business is using validated control measures.

6.1 Determine the depth of inspection activities required

The nature of the control measure and the source of the evidence determines the depth of inspection required to verify that a food business is using effective control measures and is in compliance with SFCR 47(2) and SFCR 89(1)(c)(i) and (ii). Consistent with a risk-based approach, more in-depth inspection is required for control measures targeting significant hazards and when a control measure has not been previously validated. Conversely, evidence for hygiene-based control measures (based on good hygienic practices) does not require such in-depth review because those practices are already known to be effective. Table 1 describes the inspection activities to conduct depending on the nature of the control measure.

Table 1: Depth of inspection activity by nature of control measures
Nature of control measure Examples Depth of inspection activities

Application of control measures based on good hygienic practices (GHPs) and which already have a history of good performance or are known to be effective (hygiene – based controls)

or

Application of pre-validated control measures targeting a specific hazard (for example, at a critical control point or as a process control)

  • Verify that the source of the evidence of effectiveness is specified (step 6.2)
  • Verify the control measure is implemented and effective (step 6.5)
Application of new or alternative control measures directly targeting a specific hazard that have not been previously validated (no current knowledge or history of effectiveness; no references that they have been pre-validated)
  • Process or treatment applied as a control measure to allow the re-classification of the product to a lower risk level (for example, re-classification of a food from Listeria category 1 to category 2)
  • The use of a series of measures to control a pathogen where no one parameter is sufficient on its own (hurdle technology)
  • The use of advanced technologies (for example, high pressure processing) as a critical control point (CCP) when safety and effectiveness has not been previously proven
  • Any process or treatment intended to bring into compliance products known to be contaminated with a hazard (reconditioning)
  • Verify that the source of the evidence of effectiveness is specified (step 6.2)
  • Verify that the validation study shows that the alternative control measure is effective (step 6.3)
  • Verify the control measure is implemented and effective (step 6.5)

Once the type of control measure and depth of inspection activities have been determined, proceed with the relevant activities by applying the processes described below.

6.2 Verify that the source of the evidence of effectiveness is specified

When the review conducted in step 6.1 indicates to verify that the source of the evidence is specified, verify that the evidence identifies:

  1. the food item(s) being subjected to the control measure
  2. the control measure being applied (for example, what type of process, the processing parameter, at what point in production it is applied to the product)
  3. the source of the evidence (for example, CFIA, Codex Alimentarius Committee, a process authority, in-house personnel)

As per SFCR 89(1)(c)(i) and (ii), if a food business is required to prepare, keep and maintain a preventive control plan (PCP), the evidence that the control measure is effective must be documented in the plan. Although some food businesses are exempt from the requirement to prepare, keep and maintain a PCP, they must still comply with the requirements of SFCR 47(2) which requires all food businesses to use control measures shown by evidence to be effective.

Compare the evidence to other information available concerning the product (for example, product description in the PCP, copy of the label) and controls (for example, production records, process description). Use Table 2 to determine if the source of the evidence is properly specified.

Table 2: Determining if the source of the evidence of effectiveness is specified
If Then

the evidence contains the information identified in a) to c)

and

the product and processes to which the control measure is being applied is consistent with those indicated in the evidence (for example, a thermal process designed for meat products is being applied to meat and not applied to dairy or fish)

evidence that shows the control measure to be effective has been identified.

continue with any other inspection tasks identified in step 6.1 for the nature of the control measure.

any of the information required to assess if the evidence is present is not available

or

the product or processes to which the control measure is being applied do not reflect those indicated in the evidence

evidence that shows the control measure being applied is effective has not been identified. Additional evidence of effectiveness is required. If not available, a non-compliance to SFCR 47(2) and/or 89(1)(c)(i) or (ii) may exist.

6.3 Verify that the validation study shows that an alternative control measure is effective

When the review conducted in step 6.1 indicates to verify that the validation study shows that the alternative control measure is effective, verify that:

Use the Verification of validation checklist in Appendix 1 as a tool to guide the inspection of the documentation. The checklist does not need to be completed or maintained as a record for each inspection; however, it may prove useful to help identify potential gaps in the evidence or questions to ask of subject matter experts, if required.

6.4 Seek subject matter expertise as required

After reviewing the validation information for a control measure, consult subject matter experts if support is required to determine compliance. In particular, seek subject matter expertise from the Operational Guidance and Expertise (OGE) Division when evaluating validation information for any new or alternative control measures designed to address a specific hazard.

When seeking advice from subject matter experts, first identify any potential issues and missing information as well as any specific questions for which guidance is required. To seek subject matter expertise, use the established communication channels to submit an electronic Request for Action Form (e-RAF) that includes, where possible, the information identified on the checklist in Appendix 1.

6.5 Verify that the control measures are implemented and effective

Within the scope of a PCP inspection, review available documentation, including monitoring and verification records for CCPs, and carry out other inspection activities to assess if:

Use Table 3 to identify the provision of SFCR to which a non-compliance may exist.

Table 3: Identifying non-compliance to the SFCR
If Then
the inspection activities indicate that the control measure implemented does not reflect the parameters described in the specified source (for example: the industry guidance that was referenced, or the validation study that was conducted) the control measure may be effective as described but there may be a non-compliance associated with implementation of the preventive control plan. There is potential non-compliance with SFCR 47(2). If the food business was required to implement a preventive control plan there may also be non-compliance to SFCR 88.
the control measures are implemented consistent with the evidence but the inspection activities indicate that the required outcome or performance criteria are not met this may be an indication that the control measures are not effective. There is potential non-compliance with SFCR 47(2).

If inspection activities indicate a potential non-compliance with the implementation or effectiveness of a control measure, conduct follow-up activities as described in the Standard inspection procedure (SIP) or Compliance Verification System (CVS) (for meat only). If food was produced using control measures that were not effective, conduct additional inspection or control activities (for example, product recall or seizure and detention) to verify product safety and mitigate risks to consumers. Consult the Standard regulatory response process and the Operational guideline – Food regulatory response guidelines to identify and initiate control actions as required.

6.6 Complete the inspection case

Record the inspection results for evidence of effectiveness of a control measure in the appropriate data system and in accordance with the SIP or CVS (for meat).

7.0 Appendix

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).

Appendix 1 – Verification of validation checklist

This checklist serves to guide the inspectorate when reviewing validation information. It is not required that all boxes be checked off to conclude that the validation study is adequate; in fact, it is highly unlikely that any one study would include all the options included below.

Although the information is presented in a checklist format with spaces for notes, completing the checklist is optional. However, inspection staff is encouraged to use this tool to help formulate questions or comments when seeking subject matter expertise from the OGE.

  1. Confirm the type and depth of evidence needed for the control measure:

    Q1. Is the control measure designed to have a quantitative effect on a specific hazard?

    Box No – these are generally hygiene-based control measures that do not require in-depth validation studies. They must still be effective based on literature search or in-house observations/data. Inspection activities should focus on effective implementation to meet the required outcome. Further consideration of the questions below is not required.

    Box Yes – these are controls for significant hazards. Refer to Q2.

    Q2. Is the control measure based on pre-validated control measures such as:

    Box CFIA guidance document,

    Box publications issued by provincial, national or international governments,

    Box scientific publications, and/or

    Box recommendations from the manufacturer of a processing equipment or packaging material?

    Box Yes, pre-validated by at least one source listed – refer to Q3

    Box No, not pre-validate by any of the sources listed above – This control measure is likely a new or alternative control measure. Refer to part B.

    Q3. Does the documentation (for example: preventive control plan) specify the source of the reference?

    Box Yes – Refer to Q4.

    Box No – the documentation does not adequately demonstrate that the control measure is effective. Unless additional evidence of effectiveness is available, a non-compliance to SFCR 47(2) and/or 89(1)(c)(i) or (ii) may be determined without further assessment.

    Q4. Are the conditions for application of the pre-validated control measure the same in practice as in the specified reference? For example: applied to the same type of product and processing method for which it was designed.

    Box Yes – the documentation is adequate. Inspector may still need to inspect to confirm that the operator is implementing the control measure effectively. However, a more in-depth review of the documented evidence is not required.

    Box No – the documentation may not adequately demonstrate compliance to the requirements for evidence that the control measure is effective. Unless additional evidence of effectiveness is available, a non-compliance to SFCR 47 (2) and/or 89(1)(c)(i) or (ii) may be determined without further assessment.

  2. Review of validation documentation for new or alternative control measures:

    Q1. Type of approach: what type of approach does the operator use to obtain evidence that the control measure is effective?

    Box Literature review

    Box Collection of data

    Box Challenge studies

    Box Predictive modelling

    Box Surveys

    Notes:

    Q2. Study design: does the study identify the specific control measure that is being validated?

    Box Yes

    Box No

    Q3. Study design: does the validation study define any of the following parameters/criteria?

    Box Yes

    Box the parameters (for example, internal temperature, pressure, pH, concentration level or fill weight)

    Box the acceptance criteria

    Box the acceptable variability

    Box the limit of precision or confidence level (for example, the ability of a metal detector to detect metal fragments greater than or equal to 0.5 mm at a 95% confidence level)

    Box No

    Q4. Study design: who performed or contributed to the validation study?

    Box In-house

    Box Professional process authority

    Box Accredited laboratory

    Box Academic institution

    Box Other third-party consultant

    Notes:

    Q5: Study design: does the validation documentation identify how each person is qualified or competent for their role in the study?

    Box Yes

    Box No

    Notes:

    Q6. Study methodologies: does the documentation include the following details about the study?

    Box Yes

    Box study start and completion dates

    Box equipment used

    Box type of data collected, such as time, temperature, humidity, moisture content and/or specific microorganisms identified.

    Box statistically based sampling plan, if applicable

    Box test methodology, why the method was selected for the specific food commodity and control measure, the laboratory that conducted the testing and its qualifications

    Box method selected for analyzing study results

    Box reference to challenge study guidelines, as applicable.

    Box No

    Q7. Analysis of results: which of the following are analyzed to support the findings in the validation study?

    Box All of the scientific, technical and observational information and results from the study, including, as applicable:

    Box  process records

    Box  test results

    Box certificates of analysis

    Q8. Analysis of results: does the analysis in the validation study show that the hazard is consistently addressed and makes a conclusion regarding the effectiveness of the control measure?

    Box Yes

    Box No

    Notes:

    Q9. Analysis of results: is the analysis based on the worst case scenario?

    Box Yes

    Box No

    Notes:
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